FDA 510(k)

Ahead 300

K-Number: K161068 · 2016-09-22

Decision Date2016-09-22

Product CodePIW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Ahead 300 is the device name listed in this FDA 510(k) record. The listed applicant is Brainscope Company, Inc.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K161068. The device is classified under product code PIW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ahead 300?

Ahead 300 is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Brainscope Company, Inc.. The 510(k) number is K161068.

When did Ahead 300 receive FDA 510(k) clearance?

Ahead 300 received FDA 510(k) clearance on 2016-09-22, under 510(k) number K161068.

Who is the listed applicant for Ahead 300?

The FDA 510(k) record lists Brainscope Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ahead 300?

The FDA product code for Ahead 300 is PIW.

Other records listing Brainscope Company, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190815BrainScope TBI K183241BrainScope TBI (Model: Ahead 400)K181785Modified BrainScope One K181179BrainScope One

Related Devices (Code: PIW)

K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd.K190815BrainScope TBIBrainscope Company, Inc.K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc.K181785Modified BrainScope OneBrainscope Company, Inc.K181179BrainScope OneBrainscope Company, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.